Comparison of four surgical approaches for rectal prolapse: multicentre randomized clinical trial

J Smedberg, W Graf, K Pekkari, F Hjern, J Smedberg, W Graf, K Pekkari, F Hjern

Abstract

Background: Several different procedures have been described for surgical treatment of rectal prolapse and consensus on the optimal approach has not been reached. The Swedish Rectal Prolapse Trial was performed with the aim to compare the outcomes after the most common surgical approaches to rectal prolapse.

Method: A multicentre randomized trial was conducted from 2000 to 2009. Patients were randomized between a perineal or an abdominal approach for correction of rectal prolapse (randomization A) if eligible for any procedures. Patients considered unsuitable for random allocation were only included in randomizations B or C. Patients in randomization B (perineal group) were randomized to Delorme's or Altemeier's procedures and those in randomization C (abdominal group) to suture rectopexy or resection rectopexy. Primary outcomes were bowel function and quality of life, measured using Wexner incontinence score and RAND-36, and secondary outcomes were complications and recurrence at 3 years.

Results: During the study period, 134 patients were randomized: 18 in randomization A group, 80 in randomization B group and 54 in randomization C group; of these, 122 patients underwent surgery. Mean follow-up was 2.6 years. Improvements in Wexner and RAND-36 scores were seen but with no significant difference between the groups. Health change scores were significantly improved from baseline up to 1 year after surgery (P < 0.001). At 3 years, recurrence rates were two of seven patients for abdominal versus five of eight patients for perineal approach (P = 0.315), 18 of 31 patients (58 per cent) for Delorme's versus 15 of 30 patients (50 per cent) for Altemeier's (P = 0.611) and four of 19 patients (21 per cent) for suture rectopexy versus two of 21 patients (10 per cent) for resection rectopexy (P = 0.398). There were no significant differences regarding postoperative complications.

Conclusion: For all procedures, significant improvements from baseline in health change scores were noted after surgery. Recurrence rates were higher than previously reported. Registration number: NCT04893642 (http://www.clinicaltrials.gov).

© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.

Figures

Fig. 1
Fig. 1
Trial design
Fig. 2
Fig. 2
a–c CONSORT diagram for each randomization arm
Fig. 2
Fig. 2
a–c CONSORT diagram for each randomization arm
Fig. 2
Fig. 2
a–c CONSORT diagram for each randomization arm
Fig. 3
Fig. 3
Development of quality-of-life scores (RAND-36) over time a Randomization A: abdominal versus perineal. b Randomization B: Delorme’s versus Altemeier’s. c Randomization C: suture versus resection rectopexy. d All patients.
Fig. 4
Fig. 4
Time to recurrence of rectal prolapse a Randomization A: abdominal versus perineal. P* = 0.184. b Randomization B: Delorme’s versus Altemeier’s. P* = 0.309. c Randomization C: suture versus resection rectopexy. P* = 0.426. *log rank test.

References

    1. Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev 2015;(11)CD001758
    1. Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg 2005;94:207–210
    1. Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse. Arch Surg 2005;140:63–73
    1. Joubert K, Laryea JA. Abdominal approaches to rectal prolapse. Clin Colon Rectal Surg 2017;30:57–62
    1. Schiedeck TH, Schwandner O, Scheele J, Farke S, Bruch HP. Rectal prolapse: which surgical option is appropriate? Langenbecks Arch Surg 2005;390:8–14
    1. Delorme, R. Sur le traitment des prolapses du rectum totaux pour l’excision de la muscueuse rectale ou rectocolique. In: Bulletin et Mémoires de la Société des Chirurgiens de Paris, 1900, 499–518
    1. Altemeier WA, Culbertson WR, Schowengerdt C, Hunt J. Nineteen years’ experience with the one-stage perineal repair of rectal prolapse. Ann Surg 1971;173:993–1006
    1. Hori T, Yasukawa D, Machimoto T, Kadokawa Y, Hata T, Ito Tet al. . Surgical options for full-thickness rectal prolapse: current status and institutional choice. Ann Gastroenterol 2018;31:188–197
    1. Bachoo P, Brazzelli M, Grant A. Surgery for complete rectal prolapse in adults. Cochrane Database Syst Rev 2000;2:CD001758.
    1. Luukkonen P, Mikkonen U, Jarvinen H. Abdominal rectopexy with sigmoidectomy vs. rectopexy alone for rectal prolapse: a prospective, randomized study. Int J Colorectal Dis 1992;7:219–222
    1. McKee RF, Lauder JC, Poon FW, Aitchison MA, Finlay IG. A prospective randomized study of abdominal rectopexy with and without sigmoidectomy in rectal prolapse. Surg Gynecol Obstet 1992;174:145–148
    1. Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NCet al. . PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis 2013;15:858–868
    1. Bakx R, Sprangers MA, Oort FJ, van Tets WF, Bemelman WA, Slors JFet al. . Development and validation of a colorectal functional outcome questionnaire. Int J Colorectal Dis 2005;20:126–136
    1. Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom Met al. . The Swedish RAND-36 Health Survey – reliability and responsiveness assessed in patient populations using Svensson’s method for paired ordinal data. J Patient Rep Outcomes 2018;2:4
    1. Pagels AA, Stendahl M, Evans M. Patient-reported outcome measures as a new application in the Swedish Renal Registry: health-related quality of life through RAND-36. Clin Kidney J 2019;13:442–449
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–213
    1. Deen KI, Grant E, Billingham C, Keighley MR. Abdominal resection rectopexy with pelvic floor repair versus perineal rectosigmoidectomy and pelvic floor repair for full-thickness rectal prolapse. Br J Surg 2005;81:302–304
    1. Emile SH, Elbanna H, Youssef M, Thabet W, Omar W, Elshobaky Aet al. . Laparoscopic ventral mesh rectopexy vs Delorme’s operation in management of complete rectal prolapse: a prospective randomized study. Colorectal Dis 2017;19:50–57
    1. Karas JR, Uranues S, Altomare DF, Sokmen S, Krivokapic Z, Hoch Jet al. . No rectopexy versus rectopexy following rectal mobilization for full-thickness rectal prolapse: a randomized controlled trial. Dis Colon Rectum 2011;54:29–34
    1. Lundby L, Iversen LH, Buntzen S, Wara P, Hoyer K, Laurberg S. Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study. Lancet Gastroenterol Hepatol 2016;1:291–297
    1. Consten EC, van Iersel JJ, Verheijen PM, Broeders IA, Wolthuis AM, D’Hoore A. Long-term outcome fter laparoscopic ventral mesh rectopexy: an observational study of 919 consecutive patients. Ann Surg 2015;262:742–747
    1. Evans C, Stevenson AR, Sileri P, Mercer-Jones MA, Dixon AR, Cunningham Cet al. . A multicenter collaboration to assess the safety of laparoscopic ventral rectopexy. Dis Colon Rectum 2015;58:799–807
    1. Abraham NS, Young JM, Solomon MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery 2006;139:469–483

Source: PubMed

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