To examine the recording of surgical treatments for rectal prolapse in secondary care and explore definitions for establishing establishing the use of surgical mesh: a linked CPRD and HES data feasibility study.

Study type
Feasibility Study
Date of Approval
Study reference ID
FS_003166
Lay Summary

Rectal prolapse occurs when the wall of the rectum becomes weakened and passes down through the anus. It is a disabling condition and can result in serious complications that negatively impact a patient’s quality of life. It may cause constipation, incontinence, pain and discomfort, and discharge of mucus or blood from the rectum.
There are conservative and surgical treatments for this condition. Non-surgical treatments focus on managing symptoms and reducing the prolapse. In individuals with significant rectal prolapse, they may require surgical treatment. Rectopexy is one surgical method which involves fixation of the bowel to support its position, prevent further prolapse and improve function. This procedure can be performed with or without the use of a surgical mesh to fixate the bowel. The MHRA is undertaking a review into the use of surgical mesh in rectopexy procedures. This review runs alongside the ongoing monitoring of the use of surgical mesh for treating stress urinary incontinence and prolapse of other organs in the pelvis. Serious adverse complications had been reported in some patients who had undergone such procedures using surgical mesh. These safety concerns with surgical mesh were also considered as a case study in The Independent Medicines and Medical Devices Safety Review (IMMDS).
This study aims to improve our understanding of the recording of surgery for rectal prolapse, including use of surgical mesh, to better define variables in future studies to investigate postoperative complications associated with mesh rectopexy procedures. These studies may be conducted in CPRD and other healthcare databases.

Technical Summary

The MHRA are currently undertaking a review of rectopexy procedures using surgical mesh to treat rectal prolapse. Rectopexy involves the fixation of the rectum to support the position of the anatomy, to minimise further prolapse and improve functionality. The fixation can be performed with and without the use of surgical mesh. During the Independent Medicines and Medical Devices Safety Review (IMMDS) review, it highlighted concerns in identifying the use of mesh in surgical procedures treating stress urinary incontinence and uro-gynaecological prolapse, and therefore the difficulty in quantifying the size of population at risk. These concerns remain valid for identifying the use of mesh in rectopexy procedures.
The study will explore the recording of rectopexy and the alternative procedures in secondary care data. The population who had a rectopexy performed using fixation with and without mesh during the study period would be estimated. The population who had an alternative surgical procedure to treat rectal prolapse would also be estimated.
This study will use CPRD Aurum data with linked Hospital Episode Statistics Admitted Patient Care (HES-APC) data set. It will aim to quantify the number of surgical procedures performed for rectal prolapse between April 2011-March 2021, by patient age, gender, the type of procedure and by mesh usage. The study will measure within the study population, the number of patients who had a record indicative for rectal prolapse and those who had a diagnosis of vaginal prolapse or a surgical treatment for vaginal prolapse, as rectal prolapse can be secondary to vaginal prolapse.
The findings of this study will be used to support the development of a case definition for establishing rectopexy procedures using mesh in secondary care data. It will also aid in the planning of safety monitoring activities, including epidemiological studies to explore post-operative complications associated with rectopexy procedures.

Health Outcomes to be Measured

In HES data, the following outcomes will be measured during the study period: rectal prolapse; intussusception; vaginal prolapse; abdominal rectopexy with and without surgical mesh; other abdominal operations for prolapse of rectum; and perineal operations for prolapse of rectum; surgical treatments for vaginal prolapse.
The following outcome measurements would be calculated from the HES-APC data:
•The number of patients with their first surgical procedure for rectal prolapse identified during the study period. This will be the study cohort. Use of codes that indicate use of mesh will be explored within the cohort.
•The proportion of the study cohort who had a ICD-10 diagnostic code for rectal prolapse or intussusception recorded, with an event date in the 12 months prior to or on the same date as their index date.
•The number of patients within the study cohort who had a ICD-10 diagnostic code for vaginal prolapse or a OPCS-4 code for a surgical procedure to treat vaginal prolapse procedure recorded in the 12 months prior to or on the same date as their index date.
•The frequency of recurrence of a rectal prolapse operation code recorded during the study period after the study patient’s index date.
•The frequency counts of other OPCS-4 codes recorded with the same event date as the date recorded against the OPCS-4 code for a rectal prolapse operation in the HES-APC data.
Based on the above outcome measures listed above, an algorithm for identifying procedures using mesh and the type of mesh used would be developed.

Collaborators

Katherine Donegan - Chief Investigator - MHRA
Jenny Wong - Corresponding Applicant - MHRA
Helen Booth - Collaborator - CPRD

Linkages

HES Admitted Patient Care