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.: PACTR202310528525409 Date of Approval: 31/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative study between Stapled hemorrhoidopexy and harmonic scalpel hemorrhoidectomy in third-degree and fourth-degree circumferential piles: a randomized clinical trial
Official scientific title A comparative study between Stapled hemorrhoidopexy and harmonic scalpel hemorrhoidectomy in third-degree and fourth-degree circumferential piles: a randomized clinical trial
Brief summary describing the background and objectives of the trial Background: The complexity of piles management necessitates the development of new techniques on a regular basis in order to achieve the safest and most successful technique with a high level of patient satisfaction, one of the most difficult aspects of piles surgeries. This study compares two of the most effective techniques in piles management based on post-operative results. Objective: To compare results of stapled hemorrhoidopexy (SH) and harmonic scalpel hemorrhoidectomy (HSH) in the management of Grade III and Grade IV regarding time of procedure, post-operative outcomes in the form of post-operative pain, patient satisfaction, wound infection, post operative bleeding, incontinence and recurrence within one year.
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 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Stapled Hemorrhoidpexy 32min All procedures were performed by the same surgical team under spinal or general anesthesia in the lithotomy position. All patients had a single dose of 1 g of a third-generation cephalosporin intravenously at the induction of anesthesia. Steps of procedures satrated with the external device (transparent anoscope) of PPH stapler (PROXIMATE PPH Hemorrhoidal Circular Stapler Set; Ethicon US, LLC, United states, New Jersey) was applied and fixed to the cutaneous margin with silk 0 .Double purse-string suture were inserted with submucosal bites of the lower rectum circumferentially using a 3/0 propylene (26-mm half-circle needle) at a level just a few millimeters distal to the apex of anal cushions the second purse string was taken distal to the first one after applying a little pulling force on the first purse string suture .The anvil (head) was inserted beyond the purse-string sutures, and then the purse-string was tied over the stem of the anvil firmly ( the proximal one was tied first).The stapler then was tied and kept closed for 60 s for hemostasis then fired . Untying the stapler then gently withdrawn. In women, the posterior vaginal wall was routinely checked before firing the stapler to secure non entrapment . Hemostasis along the staple line was done then ensured, and if required, a 3–0 vicryl suture was used in case of bleeding. 35 Active-Treatment of Control Group
Experimental Group Harmonic scaple hemorrhoidectomy 35 min All procedures were performed by the same surgical team under spinal or general anesthesia in the lithotomy position. All patients had a single dose of 1 g of a third-generation cephalosporin intravenously at the induction of anesthesia. A mosquito forceps or non-toothed forceps was used to grab each hemorrhoidal complex . At the beginning the external component of the hemorrhoid is dissected from the surrounding tissue and underlying external sphincter by taking a small bite between the harmonic blades (Ethicon Endo-Surgery Inc., Cincinnati, OH, USA) then proceeding more proximal underneath the hemorrhoid bundle which was delicately separated from the internal anal sphincter using sequential coagulation with the harmonic scalpel blade on the power mode 3 .The same steps were carried out regarding the other hemorrhoids, leaving a skin bridge between them . Hemostasis was done by cautery device and gel foam sponge. The wound was left open, and an external pack of gauze was applied. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients who are above 18 years old Patients with third-degree and fourth-degree circumferential piles Patients with American Society of Anesthesiologists scores I and II. patient who are less than 18 years old refusing to do surgery, Patients with debilitating diseases such as liver cirrhosis and bleeding tendencies Patients with previous anal surgeries or recurrent hemorrhoids Patients with hemorrhoids accompanied by other anal conditions such as fissure, fistula, or anal stenosis or complicated hemorrhoids Virgin female patients, Patients with previous anal surgery, Inflammatory Bowel Disease as Crohn’s, tuberculosis and patients with history of fecal incontinence. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 01/11/2021 Ain Shams ethical committee
Ethics Committee Address
Street address City Postal code Country
Abasia street Cairo 11822 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of procedure, post operative pain , patient satisfaction, recurrence, bleeding , wound infection, incontinence Two weeks , three months
Secondary Outcome Golden procedure for pile management 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital Abbasia street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university Abbasia Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philobater Awad filopatirbahgat0100071@med.asu.edu.eg 0020101846547 Nozha
City Postal code Country Position/Affiliation
Cairo Egypt Ain shams university
Role Name Email Phone Street address
Public Enquiries Basma Hassan basmabasam0100667@med.asu.edu.eg 00201224229004 Sheraton
City Postal code Country Position/Affiliation
Cairo Egypt Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Nada drmoahemd_nada@med.asu.edu.eg 01289788908 Shorouq
City Postal code Country Position/Affiliation
Cairo Egypt Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan from January 2022 to December 2022 Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information