Constipation

Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: A randomised controlled trial (2020)

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Type of publication:
Conference abstract

Author(s):
Grossi U.; McAlees E.; Knowles C.H.; Stevens N.; Di Tanna G.L.; Marlin N.; *Lacy-Colson J.; Brown S.; Scott S.M.; Norton C.; Mason J.

Citation:
Techniques in Coloproctology; 2020; vol. 24 (no. 4); p. 373-374

Abstract:
Background: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence.
Methods: An individual level, stepped-wedge randomised trial has been designed to allow observer blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate. They will be randomised to three arms with different delays before surgery (0, 12 and 24 weeks). Efficacy outcome data will be collected at equally stepped time points (12, 24, 36 and 48 weeks). The primary objective is to determine clinical efficacy of LVMR compared to controls with reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) at 24 weeks serving as the primary outcome. Secondary objectives are to determine: (1) the clinical effectiveness of LVMR to 48 weeks to a maximum of 72 weeks; (2) preoperative determinants of outcome; (3) relevant health economics for LVMR; (4) qualitative evaluation of patient and health professional experience of LVMR and (5) 30-day morbidity and mortality rates.
Results: An individual-level, stepped-wedge, randomised trial serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the waiting-listed participants an opportunity to obtain the intervention at a later date. Conclusions: In keeping with the basic ethical tenets of this design, the average waiting time for LVMR (12 weeks) will be shorter than that for routine services (24 weeks).

Surgery for constipation: systematic review and practice recommendations: Results II: Hitching procedures for the rectum (2017)

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Type of publication:
Systematic Review

Author(s):
Grossi U.; Knowles C.H.; Mason J.; *Lacy-Colson J.; Brown S.R.; Campbell K.; Chapman M.; Clarke A.; Cruickshank

Citation:
Colorectal Disease; Sep 2017; vol. 19 ; p. 37-48

Abstract:
Aim: To assess the outcomes of rectal suspension procedures (forms of rectopexy) in adults with chronic constipation. Method: Standardised methods and reporting of benefits and harms were used for all Capacity reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. Results: Eighteen articles were identified, providing data on outcomes in 1238 patients. All studies reported only on laparoscopic approaches. Length of procedures ranged between 1.5 to 3.5 h, and length of stay between 4 to 5 days. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 5-15%, with mesh complications accounting for 0.5% of patients overall. No mortality was reported after any procedures in a total of 1044 patients. Although inconsistently reported, good or satisfactory outcome occurred in 83% (74-91%) of patients; 86% (20-97%) of patients reported improvements in constipation after laparoscopic ventral mesh rectopexy (LVMR). About 2-7% of patients developed anatomical recurrence. Patient selection was inconsistently documented. As most common indication, high grade rectal intussusception was corrected in 80-100% of cases after robotic or LVMR. Healing of prolapse-associated solitary rectal ulcer syndrome occurred in around 80% of patients after LVMR.
Conclusion: Evidence supporting rectal suspension procedures is currently derived from poor quality studies. Methodologically robust trials are needed to inform future clinical decision making.