Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403582262947 Date of Approval: 20/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Stapled Transanal Rectal Resection Procedure using Single versus Double Stapler in Surgical Management of Obstructed Defecation
Official scientific title Stapled Transanal Rectal Resection Procedure using Single versus Double Stapler in Surgical Management of Obstructed Defecation: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Rectal intussusception is an infolding of the rectal wall that may occur during the act of defecation. In patients with symptoms of rectal evacuation dysfunction, rectal intussusception is a common finding at evacuation proctography. It can cause symptoms of obstructed defecation, fecal incontinence, incomplete rectal evacuation and pain. Stapled trans-anal rectal resection using PPH staplers is widely used in the treatment of intussusception with good results. This study aimed to assess the safety and efficacy of Stapled Trans-anal Rectal Resection (STARR) procedure performed by a single or double stapler through clinical and functional outcomes for trans-anal stapled surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group STARR using single PPH stapler During the surgery Preoperative preparation: a cleansing enema was given, and the patient received a routine antibiotic prophylaxis (cefotaxime 2 g and metronidazole 500 mg intravenously), immediately after the induction of anesthesia. The operation was performed under spinal anesthesia, with the patient in lithotomy position. A circular stapler with a disposable circular anal dilator and a purse string suture anoscope were used (PPH-03™; Ethicon Endo-Surgery, Inc., Pomezia, Italy). The anal verge was gently dilated with one and then two fingers for 60 seconds, two radial stitches were applied to the perineal skin to better expose the anal verge, and the lubricated obturator of the dilator was introduced and left in for 60 seconds. Finally, the lubricated anal dilator (CAD 33) was gently introduced into the anal canal and held by knotting stitches. The posterior rectal wall was protected by a retractor, inserted in the lower hole on the CAD 33, and pushed along the anal canal. Five separated parachuting sutures with Prolene™ 2-0 (Ethicon, Somerville, NJ), including mucosa, submucosa, and rectal muscle wall, were inserted 1 to 2 cm above the hemorrhoidal apex to include the top of internal rectal prolapse at 12, 2, 4, 8 and 10 o’clock. The 33-mm circular stapler was opened, and the head placed above the five anterior parachuting sutures. In females before firing the stapler, the posterior vaginal wall was carefully checked to prevent entrapment. The stapler was then fired and gently withdrawn. 24
Control Group STARR using double PPH stapler During the surgery The same preoperative preparation as the experimental group. Sutures were placed at 12, 3 and 9 o’clock regarding the anterior half and 6, 3 and 9 o’clock regarding the posterior half. 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults Male or female Persistence of at least three specific symptoms of obstructed defecation syndrome due to rectal intussusception Good response to conservative treatment External rectal prolapse Pelvic floor dyssynergia Inflammatory bowel disease Neoplasia Anorectal stenosis Anterior resection with rectal anastomosis Inability to follow up Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 14 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/02/2022 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Obstructed defecation syndrome score Preoperative, 3 months postoperatively, and 6 months postoperatively
Secondary Outcome Operative time Postoperatively
Secondary Outcome VAS pain score Postoperatively
Secondary Outcome Bleeding Postoperatively
Secondary Outcome Defecation urgency Preoperative, 3 months postoperatively, and 6 months postoperatively
Secondary Outcome Incontinence to flatus Preoperative, 3 months postoperatively, and 6 months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Osama Refaei Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospital Kasr Al Ainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Osama Refaei osama.refaei911@gmail.com +201012400838 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of General Surgery Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Osama Refaei osama.refaei911@gmail.com +201012400838 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of General Surgery Faculty of Medicine Cairo University
Role Name Email Phone Street address
Principal Investigator Ali Shafik ali@alishafik.com +20111644419 35 Mossadak St.
City Postal code Country Position/Affiliation
Cairo Egypt Professor and Chairman of Colorectal Department Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication. Study Protocol From 12 to 36 months after article publication Data will be accessible to researchers to be used for systematic reviews or meta-analyses based on a reasonable request to the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/03/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/03/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information