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ORIGINAL ARTICLE
Year : 2020  |  Volume : 8  |  Issue : 1  |  Page : 9-14

Surgical outcome and ethics in adopting new surgical technique in low resource settings: A case study in haemorrhoid surgery


1 Department of Surgery, NSCB Medical College, Jabalpur, Madhya Pradesh, India
2 Department of General Surgery, NSCB Medical College, Jabalpur, Madhya Pradesh, India

Date of Submission29-Sep-2020
Date of Acceptance09-Dec-2020
Date of Web Publication19-Jan-2021

Correspondence Address:
Dr. Ashutosh Silodia
Department of General Surgery, NSCB Medical College, Jabalpur, Madhya Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ssj.ssj_41_20

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  Abstract 

Introduction: Our aim was to evaluate the surgical outcome and ethical considerations in adopting stapled hemorrhoidopexy (SH) in low-resource settings.
Methods: This prospective comparative study of patients with Grade III hemorrhoids was conducted at our institute from December 2017 to July 2019. Short-term surgical outcome and the results of a short questionnaire associated with ethics were evaluated.
Results: Sixty patients were operated on for third-degree hemorrhoids, thirty each in Group conventional hemorrhoidectomy (CH) and Group SH. The SH group had better postoperative pain control at 0, 1, and 4 weeks (P = 0.001), but this difference became insignificant at 12 weeks. Overall recurrence was more in SH group (11.37%) as compared to CH group (2.7%), and it was statistically significant (P = 0.01). The mean operative time was significantly less in the SH group (43 min vs. 50 min, P = 0.006). Similarly, the mean hospital stay was significantly less in the SH group as compared to the CH group (2.27 days vs. 3.83 days, P = 0.001). Survey of the operating surgeons revealed that all the three surgeons involved assessed the effectiveness and safety of SH through literature; the main motivation behind performing new technique in resource-poor settings was learning a new technique and teaching purpose.
Conclusion: The main value of this research is to describe the adoption of surgical stapler into clinical practice in low-resource settings. Our analysis suggests that, in a rapidly developing area of surgical innovation, adoption of SH in resource-poor settings can give the same outcome as in expert hands.

Keywords: Hemorrhoidectomy, outcome, stapled hemorrhoidopexy


How to cite this article:
Singh P, Baghel A, Silodia A, Saytode VP, Yadav SK, Damde H, Kothari R. Surgical outcome and ethics in adopting new surgical technique in low resource settings: A case study in haemorrhoid surgery. Saudi Surg J 2020;8:9-14

How to cite this URL:
Singh P, Baghel A, Silodia A, Saytode VP, Yadav SK, Damde H, Kothari R. Surgical outcome and ethics in adopting new surgical technique in low resource settings: A case study in haemorrhoid surgery. Saudi Surg J [serial online] 2020 [cited 2021 Oct 26];8:9-14. Available from: https://www.saudisurgj.org/text.asp?2020/8/1/9/307422


  Introduction Top


The World Health Organization's ambition of universal health coverage by 2030 suffers from adverse ground realities in low- and middle-income countries (LMICs).[1],[2] India is an emerging LMIC, but many parts of this country are still low-resource settings. Finances to cover health-care costs, on an individual or societal basis, are scarce in LMICs, leading to less supply of medication, equipment, supplies, devices along with underdeveloped infrastructure (electricity, transportation, buildings, and operation theaters), and fewer or less-trained personnel. Even if enough human resources are available, there is a delay in reaching newer technologies and surgical devices. We aimed to evaluate the impact of this phenomenon in hemorrhoid surgery.

With up to 10 million people in the USA reported to be affected and despite the fact that humankind has recorded the disease for centuries and treatment has been tried as early as 1700 BC in Egyptian papyrus, the debate for an ideal treatment for hemorrhoids still continues.[3] Dietary and lifestyle modification, medical treatment, and/or office-based procedures such as rubber band ligation and sclerotherapy are the mainstay of management for low-graded internal hemorrhoids. An operation is usually indicated in low-grade hemorrhoids not responding to nonsurgical treatment, high-graded hemorrhoids, and strangulated hemorrhoids.[4],[5],[6] Conventional hemorrhoidectomy (CH) should typically be offered to patients whose symptoms result from external hemorrhoids or combined internal and external hemorrhoids with prolapse (Grades III–IV).[7] The Milligan-Morgan technique is considered the standard of care to which newer techniques are compared.[8] Stapled hemorrhoidopexy (SH), also known as a procedure for prolapse and hemorrhoids (PPH), is an alternative operation for treating advanced internal hemorrhoids described by Longo in 1998.[7] PPH was described as an ideal treatment due to its association with a shorter operating time, less postoperative pain, and shorter period of convalescence.[8],[9] Since 1998, at least thirty randomized controlled trials (RCTs) have been conducted globally to evaluate the short-term and long-term sequelae. A meta-analysis[10] concluded that SH is associated with some short-term benefits over CH, but the overall complications are similar for both techniques except for rate of recurrent disease which is higher for SH. Keeping these evidences in mind, should this surgery be practiced in low-resource settings where resources are already scarce? None of the RCTs were conducted in low-resource settings. We conducted a prospective comparative study to evaluate the ethics, economic, and surgical outcome of SH versus CH in a low-resource setting.

Stapler for hemorrhoid surgery was not available at our institute before 2017. Our patient population is very poor who cannot afford stapler and hence this surgery was not practiced before 2017 until it was made available by the government. In our hospital, bed charges, operation theater charges, and surgical device charges are nil and patients are provided all the drugs and three meals a day free of cost.


  Methods Top


This prospective comparative study of outcomes of stapler hemorrhoidopexy versus conventional hemorrhoidectomy was conducted from December 2017 to July 2019.

Patients were divided into two groups (thirty in each), either to undergo CH (Group CH) or SH (Group SH). The study was approved by the institutional ethics committee. Written informed consent was obtained.

All patients of age >18 years who presented to our outpatient department and having Grade III hemorrhoids (according to the grading of Milles[7]) were included in the study. Patients having Grade I, II, and IV hemorrhoids and deranged coagulation profile and patients unfit for spinal/general/regional anesthesia were excluded from the study.

Survey of surgeons

Three surgeons who have been routinely performing CH at our institute agreed to learn this new surgical method and be part of the study. A short questionnaire [Annexure 1] was administered to know their opinion on ethics and safety of this new surgical technique.



Surgical technique

All operations were performed under spinal anesthesia and by three surgeons. Patients were placed in a position for lithotomy. A cleaning enema was administered. Prophylactic antibiotics were given before intubation and continued 3 days postoperatively. The hemorrhoidectomy in the CH group was performed according to the Milligan-Morgan technique. In the SH group, a hemorrhoidal circular stapler (HCS33; Ethicon Endo-Surgery, Inc., Cincinnati, Ohio, USA) was used.

Surgical outcome evaluation

The Visual Analog Scale was used postoperatively (0 indicates no pain and 10 indicates maximum pain) to score pain. Pain scores were evaluated 12 h later and on the next 3 consecutive postoperative days. Pain therapy consisted of a basic analgesia (paracetamol infusion 100 cc i.v. TDS on the 1st postoperative day and then oral diclofenac tablet) and addition of i.v. injections of paracetamol, on request. At discharge from the hospital, the patients received lactulose, 20 mL daily, and diclofenac analgesia. A follow-up examination was performed 4 and 12 weeks postoperatively.

For data management and statistical analysis, SPSS-22.0 software (SPSS Inc., Chicago, IL, USA) was used. All quantitative data were expressed as mean with standard deviation and compared with the Chi-square test. P < 0.05 was considered statistically significant.


  Results Top


Sixty patients were operated on for third-degree hemorrhoids, thirty each in Group CH and Group SH. Patient characteristics were comparable for age and sex. The characteristics of the patients in the two groups are depicted in [Table 1].
Table 1: Baseline profile and surgical outcome

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Baseline characteristics were comparable in both groups. Both CH and SH groups had postoperative bleeding, but it was statistically insignificant. The SH group had better postoperative pain control at 0, 1, and 4 weeks (P = 0.001), but this difference became insignificant at 12 weeks. Two patients in the CH group had wound infection and one had residual skin tag. The SH group did not have any wound-related complication. Anal stenosis was observed in two patients in the CH group and three patients in the SH group, which was not significant.

Overall recurrence was more in SH group (11.37%) as compared to CH group (2.7%), and it was statistically significant (P = 0.01). The mean operative time was statistically significantly less in the SH group (43 min vs. 50 min, P = 0.006). Similarly, the mean hospital stay was statistically significantly less in the SH group as compared to that of the CH group (2.27 days vs. 3.83 days, P = 0.001).

Survey of operating surgeons revealed that all the three surgeons involved assessed the effectiveness and safety of SH through literature and two of them got trained via live operative workshops and operative videos. On the question of the motivation behind performing new technique in resource-poor settings, all the three answered learning new technique as the main reason and two others mentioned teaching purpose in addition. All were aware regarding the current recommendation for SH versus CH by surgical associations, that is SH is equivalent to CH. Despite this, they performed new surgery because most surgeons in developed countries are conducting trials on SH, and it was available free of cost at our institute [Table 2].
Table 2: Survey of operating surgeons with regard to ethical consideration

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  Discussion Top


SH introduced in 1998 is still a new surgical technique in resource-poor settings, and this study has brought out surgeons' motivation to adopt new technique and surgical outcome in new hands.

Postoperative pain was significantly less at 0, 1, and 4 weeks in the SH group. This is similar to the finding of Watson et al.[11] In this largest RCT, the authors reported that SH was less painful than CH in the short term and surgical complication rates were similar between the groups. In our study, the recurrence rate was significantly higher in the SH group (16.7% vs. 6.7%). Our results are comparable to those of other large RCTs published from developed countries.[12],[13],[14] A meta-analysis by Shao et al.[15] reported that SH is associated with some short-term benefits over CH, but the total complication rates are similar for both techniques. SH is associated with a higher rate of recurrent disease, which is similar to our study.

As per the current RCTs and meta-analysis, it is evident that SH is associated with less postoperative pain, reduces the length of hospital stay, and has decreased operating time but is associated with an increased rate of recurrence. SH is associated with increased cost as compared to that of CH. Kilonzo et al.[16] concluded that, on an average, the total mean costs over the 24-month follow-up period were significantly higher for the SH arm than that for the TH arm. The quality-adjusted life-years were significantly lower for the SH arm.

These mixed results put a surgeon in a resource-poor setting in a dilemma. Should he/she make an effort to learn a new technique which is as effective as he/she is currently practicing and is associated with higher cost or just continue to perform conventional surgery? This presents many challenges above those encountered in high-income countries (HICs). Although multiple RCTs have concluded that SH is comparable to CH in the management of hemorrhoids, obtaining rigorous collection of safety and efficacy data in LMIC settings is no less important before SH can be widely adopted or discarded due to ethical, financial, and resource constraints. We did a short survey of operating surgeons to evaluate the ethics involved with the adoption of a new technique. The surgeons reviewed the available literature and recommendations from surgical associations and trained themselves before adopting this technique. Their main motive was learning a new technique and teaching the fellow residents. All the three surgeons observed that as still studies are being conducted in HICs on SH, they felt that it should be performed in LMICs. This survey shows that high ethics standard is involved with adopting new techniques in a resource-poor setting.


  Conclusion Top


The main value of this research is to describe the adoption of surgical stapler into clinical practice in low-resource settings. Our analysis suggests that, guided by ethical considerations, in a rapidly developing area of surgical innovation, adoption of SH in resource-poor settings can give the same outcome as that in expert hands. Rapid dissemination of new technologies in global surgery to improve surgical care in LMICs is warranted to assess the outcome of new techniques so that there is no delay in adopting or discarding it.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
WHO. Universal Health Coverage (UHC) and World Health Day. Available from: http://www.who.int/universal_health_coverage/en/. [Last accessed on 2020 Apr 30].  Back to cited text no. 1
    
2.
WHO. The World Health Report – Health Systems Financing: The Path to Universal Coverage; 2010. Available from: http://apps.who.int/iris/bitstream/handle/10665/44371/9789241564021_eng.pdf; jsessionid=A0992D9153F88F2CE20101593BF8BF9B? sequence=1. [Last accessed 2018 Jul 30].  Back to cited text no. 2
    
3.
Rivadeneira DE, Steele SR, Ternent C, Chalasani S, Buie WD, Rafferty JL, et al. Practice parameters for the management of haemorrhoids (revised 2010). Dis Colon Rectum 2011;54:1059-64.  Back to cited text no. 3
    
4.
Tucker H, George E, Barnett D, Longson C. NICE technology appraisal on stapled haemorrhoidopexy for the treatment of haemorrhoids. Ann R Coll Surg Engl 2008;90:82-4.  Back to cited text no. 4
    
5.
Corman ML, Gravié JF, Hager T, Loudon MA, Mascagni D, Nyström PO, et al. Stapled haemorrhoidopexy: A consensus position paper by an international working party – Indications, contra-indications and technique. Colorectal Dis 2003;5:304-10.  Back to cited text no. 5
    
6.
Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of colon and Rectal Surgeons clinical practice guidelines for the management of hemorrhoids. Dis Colon Rectum 2018;61:284-92.  Back to cited text no. 6
    
7.
Milles E. Observations upon internal pils. Surg Gynecol Obstet 1919:29497-506.  Back to cited text no. 7
    
8.
Agbo SP. Surgical management of hemorrhoids. J Surg Tech Case Rep 2011;3:68-75.  Back to cited text no. 8
    
9.
Longo A. Treatment of hemorrhoidal disease by reduction of mucosa and hemorrhoidal prolapse with a circular suturing device: A new procedure. In: Proceedings of the 6th World Congress of Endoscopic Surgery. Bologna, Italy: Monduzzi Editore; 1998. p. 777-84.  Back to cited text no. 9
    
10.
Shao WJ, Li GC, Zhang ZH, Yang BL, Sun GD, Chen YQ, et al. Systematic review and meta-analysis of randomized controlled trials comparing stapled haemorrhoidopexy with conventional haemorrhoidectomy. Br J Surg 2008;95:147-60.  Back to cited text no. 10
    
11.
Watson AJ, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A, et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): A pragmatic, multicentre, randomised controlled trial. Lancet 2016;388:2375-85.  Back to cited text no. 11
    
12.
Festen S, van Hoogstraten MJ, van Geloven AA, Gerhards MF. Treatment of Grade III and IV haemorrhoidal disease with PPH or THD. A randomized trial on postoperative complications and short-term results. Int J Colorectal Dis 2009;24:1401-5.  Back to cited text no. 12
    
13.
Infantino A, Altomare DF, Bottini C, Bonanno M, Mancini S, THD group of the SICCR (Italian Society of Colorectal Surgery), et al. Prospective randomized multicentre study comparing stapler haemorrhoidopexy with Doppler-guided transanal haemorrhoid dearterialization for third-degree haemorrhoids. Colorectal Dis 2012;14:205-11.  Back to cited text no. 13
    
14.
Verre L, Rossi R, Gaggelli I, Di Bella C, Tirone A, Piccolomini A, et al. PPH versus THD: A comparison of two techniques for III and IV degree haemorrhoids. Personal experience. Minerva Chir 2013;68:543-50.  Back to cited text no. 14
    
15.
Shao WJ, Li GC, Zhang ZH, Yang BL, Sun GD, Chen YQ. Systematic review and meta-analysis of randomized controlled trials comparing stapled haemorrhoidopexy with conventional haemorrhoidectomy. Br J Surg 2008;95:147-160.  Back to cited text no. 15
    
16.
Kilonzo MM, Brown SR, Bruhn H, Cook JA, Hudson J, Norrie J, et al. Cost effectiveness of stapled haemorrhoidopexy and traditional excisional surgery for the treatment of haemorrhoidal disease. Pharmacoecon Open 2018;2:271-80.  Back to cited text no. 16
    



 
 
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