An interventional study of STARR (Stapled Trans Anal Rectal Resection) and LVR (Laparoscopic Ventral Rectopexy) in Rectal Prolapse, Defecation Disorder and Rectocele; Female, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).
This randomized controlled trial (single center, prospective, randomized controlled, parallel, and single-blind trial) is designed to compare the outcome of patients with ODS and rectal prolapse undergoing transanal prolapsectomy with mechanical stapler (STARR) versus laparoscopic ventral rectopexy (LVR), with the aim of evaluating the most appropriate surgical choice.
The study will be conducted at the Surgical Unit 2 of the University Hospital of Ferrara, Italy. Patients suffering from rectal prolapse and ODS that will refer to the colorectal and pelvic floor clinic of the University Hospital Ferrara, and eligible for surgery, will be evaluated consecutively after expressing consent to participate in the study by signing an informed consent.
The duration of the study for each patient will be expected to be 48 months with follow-up at 1, 3, 6, 12, 24, 36, and 48 months postoperatively.
Eligible patients will receive information about participating in the trial by their surgeon. Consecutive eligible patients will be randomly assigned to one of two groups with a 1:1 equal allocation ratio.
Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR).
An independent individual will perform randomization using a software randomization program. Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.
The diagnosis of ODS will be attributed after clinical evaluation at the colorectal clinic and on the basis of the presence of one or more symptoms associated with this disorder, such as to reach a score of 14 and above according to the validated score of ODS of Altomare.
Assessment After recruitment and consent, all patients under study will be asked and collected demographic and clinical information with comorbidities (in particular diabetes, fibromyalgia, depressive disorders, neurological diseases, COPD), parity, previous pelvic surgery, type of surgery, time of hospitalization and any complications (according to Clavien-Dindo classification).
Data concerning the grade of rectoanal prolapse, according with Oxford Classification [20], and rectocele grading will be collected through outpatient proctological evaluation associated with proctoscopy, rectal manometry, and Rx defecography. Colonoscopy will be also performed in every patient to exclude colorectal cancer.
The severity of the ODS will be scored with the Altomare's ODS scoring system. Constipation and fecal incontinence will be measured by obtaining their scores through the administration of validated questionnaires such as the Wexner Constipation score, and the Cleveland Clinic Fecal Incontinence Score (CCFI).
Quality of life will be also evaluated by the patient assessment of constipation quality-of-life (PAC-Qol) questionnaire. The study of eventually associated pelvic distress will be assessed by administering validated questionnaires such as the Pelvic Floor Distress Inventory (PFDI-score, short form) and the Pelvic Floor Impact Questionnaire (PFQI-score, short form).
The scores obtained, as well as the presence of symptoms (fecal incontinence, constipation, or ODS) will be calculated before and after surgery (at 6, 12, 24, 36, and 48 months). All patients will be followed up on an outpatient basis at 7 days, 1 month, 3 months, 6 months, 12 ,24, 36, and 48 months after surgery. Rectal manometry and defecography will be performed after 12 months after surgery.
Surgical intervention All the procedures will be performed by a single surgeon (SA). The LVR technique used for this protocol is as previously described. Subjects randomized to this arm will receive a standard LVR. Briefly, the peritoneum is opened over the right side of the sacral promontory. The mesorectum is dissected and extended in an inverted J-form along the right side. The rectovaginal septum is opened to the pelvic floor. Biologic mesh (Permacol) is sutured to the ventral aspect of the rectum with non-readsorbable stitches. The proximal end of the mesh is fixed on the anterior longitudinal ligament at sacral promontory with nonabsorbable tacks. The incised peritoneum is then closed to over the mesh.
Subjects randomized to STARR arm will undergo a STARR procedure. Briefly, a circular anal dilator is introduced into the rectum. The purse-string anoscope is used to complete the anterior hemi-circumference purse-string suture, about 2-3 cm above the haemorrhoidal apex. A 33-mm circular stapler (Ethicon, ppH01) is opened, inserted until crossing the purse-string which is then tied with a knot. Then the stapler is closed and fired. The same hemi-circumference purse-string suture is performed in the posterior rectal wall. A second application of the stapler on the posterior wall is inserted, closed and fired.
The duration of the study will be 2 years. The study will be conducted in accordance with the principles of Helsinki Declaration, with approval of the medical ethics review board of S. Anna University Hospital. A written informed consent will be obtained from all enrolled patients.
The report will comply with the strengthening the reporting of randomized studies (CONSORT).
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 70 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly
Procedure: STARR (Stapled Trans Anal Rectal Resection)
Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly
Procedure: LVR (Laparoscopic Ventral Rectopexy)
Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
Evaluation of different outcomes in relief from ODS after surgery in both groups
In order to evaluate the short- and long-term efficacy of STARR procedure compared to LVR, the percentage of changes in total ODS, PAC-QoL, PFDI, PFQI, Wexner Constipation, the Cleveland Clinic Fecal Incontinence (CCFI) scores between baseline and 6, 12, 24, 36, and 48 months after surgery, were adopted as primary outcome.
Time frame: 4 years
short-term postoperative complications (within 30 days after surgery)
short-term postoperative complications (within 30 days after surgery) in the two groups (according to Clavien-Dindo classification)
Time frame: 4 years
long-term postoperative complications
Mesh-related complications, rectal stenosis
Time frame: 4 years
recurrence or persistence of rectal prolapse
to evaluate recurrence or persistence of rectal prolapse (diagnosed clinically and by postoperative defecography) in both groups, and the need for subsequent corrective surgery
Time frame: 4 years
recurrence or persistence of ODS (Obstructed defecation syndrome)
recurrence or persistence of ODS if ODS score \> 10
Time frame: 4 years
patient satisfaction in terms of pain
patient satisfaction measured by a VAS (Visual Analogue Scale: evaluation of pain in mm: from 0 to 4 mm: no pain; from 5 to 44 mm: little pain; from 45 to 74 mm: moderate pain; from 75 to 100 mm: severe pain
Time frame: 4 years
Plan to share: No
Ran from Jan 2017 to primary completion in Jan 2019, 24 months.
Of 18 interventional studies with no phase under Rectal Prolapse, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's 24 months is below that.
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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