CHAPTER ONE
CHAPTER ONE
Bowel Function after Laparoscopic Posterior Sutured Rectopexy versus Ventral Mesh Rectopexy for Rectal Prolapse: A Double-Blind, Randomised Single-Centre Study
Research Question/Objective Myriad procedures have been proposed to treat full-thickness rectal prolapse. This study sought to compare functional symptoms in patients with rectal prolapse who were treated with either laparoscopic posterior sutured rectopexy or laparoscopic ventral mesh rectopexy.
Study Design The study was a single-center, double-blind, randomized trial performed at the Department of Surgery in Aarhus University Hospital in Denmark. It enrolled patients with full-thickness rectal prolapse and randomized them to treatment with either laparoscopic posterior sutured rectopexy or laparoscopic ventral mesh rectopexy. The primary outcome was change in preoperative obstructed defecation syndrome score at one-year postoperative follow-up. Secondary outcomes included the change in patients' preoperative baselines compared to one-year postoperative follow-up in their Cleveland Clinic constipation scores, Cleveland Clinic fecal incontinence scores, and their colon transit time as measured by ingested radio-opaque markers.
Sample Size A total of one hundred seventy-six patients were assessed for eligibility with seventy-five patients enrolled from the years two thousand six to two thousand fourteen. Thirty-eight patients were randomized to ventral mesh rectopexy, while the thirty-seven other patients were randomized to posterior suture rectopexy. Thirty-three patients in the ventral mesh rectopexy arm, and thirty-four in the posterior suture rectopexy arm completed twelve-month follow-up.
Follow-Up Study follow-up occurred at one-year postoperatively, at which time, obstructed defecation syndrome score, Cleveland Clinic constipation score, Cleveland Clinic fecal incontinence score, and colon transit time were assessed. Additional assessment at one-year included a clinical examination and defecography.
Inclusion/Exclusion Criteria Patients were enrolled in the study if they had full-thickness rectal prolapse, as determined by inducible prolapse while straining on a toilet chair in clinic and were deemed suitable for a transabdominal procedure. Exclusion criteria included being a pediatric patient (under eighteen years of age), pregnancy or breast-feeding, dementia, psychiatric diseases that would preclude the ability to give informed consent, recurrent rectal prolapse, and the inability to speak or read Danish.
Intervention or Treatment Received Patients underwent either a laparoscopic posterior suture rectopexy or a laparoscopic ventral mesh rectopexy. The laparoscopic posterior suture rectopexy technique included division of the lateral rectal attachments, full posterior mobilization of the rectum, and suturing of the rectum to the sacral promontory with nonabsorbable sutures. The laparoscopic ventral mesh rectopexy included dissection of the anterior aspect of the rectum, incising the peritoneum to the right of the rectum, suturing of a polypropylene mesh to the distal ventral aspect of the rectum, securing this mesh to the sacral promontory with tacks, and closure of the incised peritoneum to cover the mesh.
Results
Results
Primary Outcome The ventral mesh rectopexy arm had a mean preoperative obstructed defecation syndrome score of nine point three, which decreased by one point nine seven at one-year follow-up. In comparison, the posterior suture rectopexy arm had a mean preoperative obstructed defecation syndrome score of ten point eight, which decreased by two point one eight at one-year follow-up. There was no difference in the obstructed defecation syndrome score decrease between the two groups (negative zero point two one, ninety-five percent confidence interval negative three point one nine to two point seven eight).
Secondary Outcomes In both arms, the Cleveland Clinic constipation score and fecal incontinence score decreased (functional improvement) at one-year follow-up. There was no difference in the decrease in either score between the two groups. Colon transit time was affected significantly more in the suture rectopexy group. The ventral mesh rectopexy group preoperatively took a mean of two point eight days [standard deviation one point five] to pass the radio-opaque markers. Their transit time did not increase when measured at one-year follow-up. This contrasted with the laparoscopic suture posterior rectopexy, when preoperatively the markers took two point five days (standard deviation one point six) to pass, which increased by one point three nine days (ninety-five percent confidence interval zero point zero five to two point seven four) at one-year follow-up. The suture rectopexy group therefore had one point one one days (ninety-five percent confidence interval zero point three three to one point eight nine) added to their transit time at one-year in comparison to the ventral mesh rectopexy.
Defecography was also obtained at one-year follow-up. The posterior suture rectopexy group had more occurrences of internal intussusception (fifty-three percent versus twenty-eight percent, P equals zero point zero four). There was no difference between patients in each arm when comparing incomplete evacuation (forty-eight percent in the ventral mesh rectopexy, forty-three percent in the posterior suture rectopexy) at one year.
Study Limitations The first and main study limitation is the patient population. It describes a relatively small sample size, with only seventy-five patients randomized in the trial with sixty-seven following up at one year. Comparison between outcomes is therefore limited due to the lack of power in the trial. It was especially not powered to detect nonfunctional outcomes such as prolapse recurrence. The study's outcomes also describe the functional outcomes for patients at a single institution in Northern Europe, which may not extrapolate to other patient populations. This study is also limited in follow-up, with only one year of postoperative outcomes reported.
The study also has limitations regarding surgical technique. The authors do not fully describe their posterior rectopexy technique with respect to the lateral rectal attachments. They do not comment on whether they took one or both stalks and whether they closed the peritoneum after their anchoring sutures.
A last group of limitations involves the surgeons. The results speak to the work of three surgeons, but a closer look at the data shows that one surgeon performed two-thirds of the operations. Another limitation is the experience of the three study surgeons in ventral mesh rectopexy. The three surgeons' combined experience prior to the study was ten ventral mesh rectopexies. This contrasts with learning curves for laparoscopic ventral mesh rectopexy published in literature, where approximately twenty-five to fifty cases were needed until operative proficiency.
Relevant Studies Treatment of rectal prolapse continues to remain an area with no definitive evidence to guide surgeons on the best operative treatment. Prior to this study, additional randomized trials had been done. One was the PROSPER trial, which compared abdominal (posterior suture rectopexy versus sigmoid resection with posterior suture rectopexy) and perineal (Altemeier versus Delorme) approaches. Ventral mesh rectopexy was not a treatment option in the trial design. The study found no differences in recurrence, bowel function, or quality of life between the treatments. This study was also limited by statistical power due to a low sample size and limited follow-up. The Swedish Rectal Prolapse Trial, conducted from two thousand to two thousand nine with results just published in twenty twenty-two, similarly showed no difference in recurrence (measured at three years in the study) but did show that for all procedures, quality of life improved for patients. Like the PROSPER trial, ventral mesh rectopexy was not included as a treatment option in the trial design.
Meta-analyses have also been published looking at the best procedure for treating rectal prolapse. A Cochrane review in twenty fifteen, which did not include ventral mesh rectopexy, concluded that recurrence rates between abdominal and perineal procedures were similar but acknowledged a large need for trials with long-term follow-up and adequate power. A more recent systematic review and meta-analysis in twenty twenty-one, which did include ventral mesh rectopexy, showed that the difference between recurrence in suture rectopexy versus ventral mesh rectopexy was not significant.
Mesh concerns arise when discussing ventral mesh rectopexy. There have been two larger studies looking at long-term mesh outcomes. One observational study that followed nine hundred nineteen patients found mesh-related complications to occur in four point six percent of patients. An additional retrospective review looked at over two thousand patients who had undergone ventral mesh rectopexy and found that two percent of the patients had mesh erosion. Of these patients, fifty-one percent needed treatment for minor erosion morbidity (such as local excision of a stitch or mesh), and forty percent had major erosion morbidity necessitating an operation for mesh explantation.
Lastly, long-term follow-up for the main study was limited. This limited follow-up was partially addressed with a recent publication from the same group, where they published their six-year follow-up outcomes. Recurrence of rectal prolapse did not differ, though the study was not powered to detect such a difference. When looking at functional outcomes, the ventral mesh rectopexy group had a significantly lower mean ODS score (six point five two) versus the posterior suture rectopexy group (nine point five), P equals zero point zero one. They also sent out an additional patient survey that they had not measured preoperatively, the Patient Assessment of Quality of Life, where the ventral mesh rectopexy group had a significantly lower (better quality of life) score compared to the suture rectopexy group. Mean ninety-five percent confidence interval zero point two six (zero point one four to zero point eight four) versus zero point nine three (zero point three two to one point six one), P equals zero point zero one.
Despite many efforts at both observational and randomized trials, there still exists a lack of quality data to help guide surgeons in treatment of rectal prolapse. This lack of data is not due to a lack of trying. Time and time again, adequate patient accruement in these trials has proven difficult, leading to underpowered studies. An alternative method for studying this pathology is needed, such as a large quality improvement registry that tracks patients' functional outcomes. We have had successful initial efforts at such a registry, and we encourage others to enroll their patients in similar efforts, so that we can start to provide the evidence-based treatment to our patients that they deserve.