- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04892108
Rectal Prolapse With ODS. STARR vs LVR.
Surgical Treatment of Internal Rectal Prolapse Associated With Obstructed Defecation: Transanal Prolassectomy Versus Laparoscopic Ventral Rectopexy. Randomized Controlled Trial.
Study Overview
Status
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ferrara, Italy, 44124
- Surgery 2 Surgical Department, Sant'Anna University Hospital Ferrara, Italy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female gender,
- the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
- type of operation performed (STARR or LVR),
- ODS score > 14 [17]
- PACQoL >32 [18]
- ODS symptoms for at least 12 months prior to enrollment
- Failure of at least 6 months of medical therapy
Exclusion Criteria:
- male gender,
- severe fecal incontinence (CCS score>6, Maximum Resting Pressure at rectal manometry < 50 mmHg),
- combined procedures
- previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
- pregnancy,
- anismus or dissinergic defecation
- full-thickness prolapse
- stress urinary incontinence associated
- histerocele or cystocele associated (since we usually correct both defects in the same surgical procedure)
- prior pelvic radiotherapy
- slow transit constipation defined as ≤ 2 bowel movements per week,
- any psychiatric diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group STARR
Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly
|
Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
|
Experimental: Group LVR
Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly
|
Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of different outcomes in relief from ODS after surgery in both groups
Time Frame: 4 years
|
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.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
short-term postoperative complications (within 30 days after surgery)
Time Frame: 4 years
|
short-term postoperative complications (within 30 days after surgery) in the two groups (according to Clavien-Dindo classification)
|
4 years
|
long-term postoperative complications
Time Frame: 4 years
|
Mesh-related complications, rectal stenosis
|
4 years
|
recurrence or persistence of rectal prolapse
Time Frame: 4 years
|
to evaluate recurrence or persistence of rectal prolapse (diagnosed clinically and by postoperative defecography) in both groups, and the need for subsequent corrective surgery
|
4 years
|
recurrence or persistence of ODS (Obstructed defecation syndrome)
Time Frame: 4 years
|
recurrence or persistence of ODS if ODS score > 10
|
4 years
|
patient satisfaction in terms of pain
Time Frame: 4 years
|
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
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simona Ascanelli, Surgical Department University Hospital Ferrara Italy
Publications and helpful links
General Publications
- Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Hicks CW, Weinstein M, Wakamatsu M, Savitt L, Pulliam S, Bordeianou L. In patients with rectoceles and obstructed defecation syndrome, surgery should be the option of last resort. Surgery. 2014 Apr;155(4):659-67. doi: 10.1016/j.surg.2013.11.013. Epub 2013 Dec 5.
- Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.
- Rao SS. Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. doi: 10.1016/s0889-8553(05)70169-2.
- Podzemny V, Pescatori LC, Pescatori M. Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053.
- Gunner CK, Senapati A, Northover JM, Brown SR. Life after PROSPER. What do people do for external rectal prolapse? Colorectal Dis. 2016 Aug;18(8):811-4. doi: 10.1111/codi.13255.
- Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.
- Emile SH, Elfeki H, Shalaby M, Sakr A, Sileri P, Wexner SD. Perineal resectional procedures for the treatment of complete rectal prolapse: A systematic review of the literature. Int J Surg. 2017 Oct;46:146-154. doi: 10.1016/j.ijsu.2017.09.005. Epub 2017 Sep 7.
- van den Esschert JW, van Geloven AA, Vermulst N, Groenedijk AG, de Wit LT, Gerhards MF. Laparoscopic ventral rectopexy for obstructed defecation syndrome. Surg Endosc. 2008 Dec;22(12):2728-32. doi: 10.1007/s00464-008-9771-9. Epub 2008 Mar 5. Erratum In: Surg Endosc. 2008 Oct;22(10):2330. Groenedijk, A [corrected to Groenedijk, A G].
- Altomare DF, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V. Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome. Colorectal Dis. 2008 Jan;10(1):84-8. doi: 10.1111/j.1463-1318.2007.01262.x. Epub 2007 Apr 18.
- Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
- Cariou de Vergie L, Venara A, Duchalais E, Frampas E, Lehur PA. Internal rectal prolapse: Definition, assessment and management in 2016. J Visc Surg. 2017 Feb;154(1):21-28. doi: 10.1016/j.jviscsurg.2016.10.004. Epub 2016 Nov 16.
- Kluivers KB, Hendriks JC, Shek C, Dietz HP. Pelvic organ prolapse symptoms in relation to POPQ, ordinal stages and ultrasound prolapse assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1299-302. doi: 10.1007/s00192-008-0634-7. Epub 2008 May 9.
- Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.
- Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
- Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
- Sileri P, Franceschilli L, de Luca E, Lazzaro S, Angelucci GP, Fiaschetti V, Pasecenic C, Gaspari AL. Laparoscopic ventral rectopexy for internal rectal prolapse using biological mesh: postoperative and short-term functional results. J Gastrointest Surg. 2012 Mar;16(3):622-8. doi: 10.1007/s11605-011-1793-2. Epub 2012 Jan 7.
- Jayne DG, Schwandner O, Stuto A. Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry. Dis Colon Rectum. 2009 Jul;52(7):1205-12; discussion 1212-4. doi: 10.1007/DCR.0b013e3181a9120f.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129/2021/Sper/AOUFe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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