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.: PACTR202508580100870 Date of Registration: 05/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laparoscopic versus open low anterior resection for rectal cancer
Official scientific title Laparoscopic versus open low anterior resection for rectal cancer
Brief summary describing the background and objectives of the trial Globally, colorectal cancer ranks as the 3rd most prevalent tumor, with about one-third of cases localized to the rectum. Despite the improvement in chemo-radiotherapy, the surgical excision of the 1ry tumor is still the mainstay for management.Recently, laparoscopic colon surgery has replaced traditional open surgery due to several advantages and favorable short-term results, like less pain after the operation, shorter postoperative ileus, better cosmesis, diminished blood loss, and shorter hospitalization In contrast, the 1st clinical trial for laparoscopic rectal cancer resection, which compared conventional versus laparoscopic-assisted surgery in colorectal cancer (CLASSIC), showed unfavorable results as regards the high rate of positive circumferential resection margin (CRM) in laparoscopic cases in comparison to the open ones (12% versus 6%). Although the long-term results of this trial and the results of others showed comparable or better survival information, the laparoscopic approach in rectal cancer resection remains controversial and widely debated. Consequently, laparoscopic technique is still not generally accepted by many surgeons due to the narrow pelvis, especially in male patients; it is technically demanding, and it needs a learning curve. Also, the morbid obesity, local infiltration of the tumor, and technical difficulties increase the rate of conversion in comparison to laparoscopic colon cancer surgery This study amied to compare the early outcomes as well as the oncological adequacy between laparoscopic and open low anterior resection for rectal cancer.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 14/02/2023
Actual trial start date 14/02/2023
Anticipated date of last follow up 02/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laparoscopic Low Anterior Resection once duration of the operation Laparoscopic low anterior resection has been conducted under general anesthesia with the case positioned in the modified lithotomy position and Trendelenburg tilt. Pneumoperitoneum was established using a Veress needle, and 3 to 4 trocars have been inserted under direct vision. The sigmoid colon has been mobilized utilizing a medial-to-lateral approach, starting with the recognition of the gonadal vessels and left ureter. The inferior mesenteric artery and vein were ligated using Hem-o-Lok clips or energy-sealing devices such as Ligasure. Rectal mobilization was performed with sharp dissection in the avascular embryological plane, following the principles of total mesorectal excision, down to the pelvic floor. Special care was taken to prevent injury to the hypogastric nerves and pelvic plexus. After full mobilization, the rectum was transected with a laparoscopic linear stapler. The proximal colon was prepared with a purse-string suture, and an anvil was inserted. A circular stapler was introduced transanally to construct an end-to-end colorectal anastomosis. The specimen has been extracted through a protected Pfannenstiel or suprapubic incision. A pelvic drain was placed, and port sites were closed under direct vision. 20
Control Group Open Low Anterior Resection once duration of the operation OLAR was carried out under general anesthesia through a midline laparotomy incision. The patient was positioned supine, and a full abdominal exploration was performed. The descending and sigmoid colon were mobilized via a medial-to-lateral dissection after identification and protection of the ureters. The inferior mesenteric artery was ligated near its origin, followed by mesenteric dissection for complete mobilization of the colon. The rectum was sharply dissected in the mesorectal plane to achieve total mesorectal excision down to the level of the pelvic floor. The rectum was transected utilizing a conventional linear stapler, and an anvil was secured to the proximal colon. A circular stapler was introduced transanally to perform an end-to-end colorectal anastomosis. The specimen has been removed through the laparotomy incision. A pelvic drain was inserted, and the abdominal layers were closed in the standard fashion. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with rectal cancer who were candidates for low anterior resection tumors located in the upper rectum (ten to fifteen centimeters from the anorectal ring), middle rectum (five to ten centimeters from the anorectal ring), and low rectum (0–5 centimeters from the anorectal ring), provided that low rectal tumors had a distal margin of more than one centimeter, with an additional one centimeter of rectum preserved to allow for a stapled anastomosis. patients with metastatic tumors those presenting with complications like bleeding, obstruction, or perforation. cases with locally advanced tumors cancer invasion into adjacent organs, pregnancy coagulopathy, Patients who weren’t candidates for low anterior resection (LAR), whether open or laparoscopic, but could instead undergo abdominoperineal resection (APR) tumor fixation to bones on digital rectal examination, inadequate distal margin even with intersphincteric dissection, involvement of the external sphincter by the tumor, preoperative fecal incontinence, poor preoperative (or predicted preoperative) sphincter function. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 67 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 14/02/2023 Faculty of Medicine Al Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
Al Azhar University Assiut Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome analyzing the length of resection safety margins, including both the distal margin and the circumferential resection margin; the number of harvested lymph nodes; the mesorectal excision quality or mesorectal grade; and the patterns and rate of local or distant tumor recurrence throughout the monitoring interval. postoperative
Secondary Outcome operative time, gastrointestinal (GIT) recovery, postoperative pain and the corresponding analgesic needs, period of hospitalization, operative morbidity, specific complications, such as postoperative sexual dysfunction; and conversion rate postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General surgery department Al Azhar University Hospital Assiut Al Azhar University Hospital Assiut Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar University Hospital Assiut Al Azhar University Hospital Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University hospital Al Azhar University hospital assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Magdy Omran magdyomran171989@gmail.com +201011102275 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant lecturer of General Surgery Al Azhar University assiut
Role Name Email Phone Street address
Public Enquiries Ahmad Hasan ahmedmohamedhassanahmed.44@azhar.edu.eg +201002851771 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor of general surgery Faculty of Medicine Al Azhar university Assiut
Role Name Email Phone Street address
Scientific Enquiries Saad Ali saadmohaly1985@gmail.com +201229183866 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant Professor of general surgery Faculty of Medicine Al Azhar university Assiut
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results of this study will be available after deidentification (text, tables, figures) Clinical Study Report,Informed Consent Form,Study Protocol data will be available 3 months and up to 12 months after article publications qualified persons only
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 05/08/2025 PACTR Admin 14 Feb 2023