Rectal prolapse occurs when part of the large intestine slips out through the anus. Symptoms can include incontinence and constipation. Treatment is mainly surgical, with a variety of approaches used and no clear agreement on the most effective method. One of the procedures involves use of a mesh device to secure the rectum in place. The risk of complications from the surgical procedure (called a rectopexy), or from the mesh when it’s used, is not well understood. Current evidence on safety of rectopexy procedures is based on small studies that might not represent the whole population well.
The aim of this study is to improve our understanding of rectal prolapse and its treatment, including use of mesh and subsequent complications. To do this we will use hospital data to find patients who have a diagnosis of rectal prolapse or rectopexy and describe their characteristics such as age, sex and type of surgical treatment. For those who underwent surgery, we will investigate how many patients experience a short-term complication requiring admission to hospital, such as infection or pain at the operation site, or who require a re-operation with a year. This study will improve our understanding of the patients who get rectal prolapse and how they are treated. It will also increase our knowledge of the risks associated with rectopexy procedures.
Rectal prolapse can be treated with a variety of surgical approaches (rectopexy), encompassing different access points, use of mesh or sutures and resection of the colon. Where biological or synthetic mesh is implanted there is a risk of mesh-related or procedural complications that are not yet well-quantified.
The aim of this study is to increase understanding on the epidemiology of rectal prolapse and its surgical management, with a particular interest in procedures involving insertion of mesh. The objectives are (1) To describe the epidemiology of rectal prolapse over the study period (01/01/2013 to 31/03/2021), including (a) incidence and prevalence, and (b) baseline characteristics (age, sex, prolapse symptoms); (2) To describe the use of rectopexy over the study period, including trends over time (stratified by procedure type, age and sex) and baseline characteristics; (3) To estimate the risk of short-term (90 days) postoperative complications or further related procedures up to one year post-index surgery.
Retrospective patient cohorts will be selected on the basis of a diagnostic code for rectal prolapse (obj 1) or procedural code for rectopexy (obj 2) using hospital admissions data. Incidence and prevalence will be calculated for rectal prolapse (obj 1) and rectopexy (obj 2), and baseline characteristics tabulated for each cohort. For objective 3, incidence of complications requiring admission (infection, pain) up to 3 months after the index procedure will be calculated. Rectopexy re-operation rate up to one year after index procedure will be explored with survival analysis using the Kaplan-Meier method.
This study will improve understanding of the epidemiology of rectal prolapse and its surgical management. It will increase our knowledge of the risks associated with rectopexy procedures, including those that involve mesh insertion.
Objective 1: Rectal prolapse
Objective 2: Rectopexy
Objective 3: (a) Short-term complications of rectopexy requiring readmission, relating to pain, haemorrhage, procedure or device; (b) further procedure relating to rectopexy
Katherine Donegan - Chief Investigator - MHRA
Helen Booth - Corresponding Applicant - CPRD
Daniel Dedman - Collaborator - CPRD
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRD
HES Admitted Patient Care