Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatments open intersphincteric resection, laparoscopic intersphincteric resection
Phase phase 2/phase 3
Sponsor Osama Mohammad Ali ElDamshety
Collaborator Mansoura University
Start date December 2012
End date December 2015
Trial size 106 participants
Trial identifier NCT01836926, Mansoura oncology centre

Summary

The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing procedures. Intersphincteric resection is procedure to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy,improves the quality of life with better genitourinary function. Neoadjuvant chemo-radiotherapy is routine for T3 cases.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
surgical Instruments for open approach intervention: Open laparotomy through abdominal incision and mobilization of the colon and rectum up to the splenic flexure with high ligation of the inferior mesenteric vessels and mesorectal excision till the levator ani then the peranal approach to resect the distal margin of the rectum through high or low intersphincteric resection in the plane between internal and external anal sphincters.
open intersphincteric resection sphincter preserving procedures in low rectal cancer
laparotomy arm: surgical Instruments for open approach operation: Abdominal anterior resection combined with peranal intersphincteric resection of the rectum Abdominal step a high ligation of the inferior mesenteric artery is performed together with a full mobilization of the left colon. A circular incision of the anal canal is performed 1 cm below the tumour. Both the mucosa and the muscular layer are incised to transect the internal anal sphincter. A coloanal anastomosis, transverse coloplasty or colonic J-pouch and a diverting loop ileostomy are associated with the hand-sewn coloanal anastomosis. laparoscopic approach group: instruments used: laparoscopic instruments mentioned at the arm description intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach
(Active Comparator)
instruments used: 4 or 5 laparoscopic trocars (two or three (10-mm) trocar, Two 5-mm trocars and a 12-mm trocar with reducers),Three 5-mm fenestrated grasping forceps, Five-millimetre coagulating shears, a 5-mm straight grasping forceps, Harmonic scalpel, 5 or 10 mm, a 10-mm fenestrated forceps, a 10-mm dissector,5 mm Bipolar grasper, a 5-mm needle holder, Twelve-millimetre linear staplers intervention: Trocar Placement and Exposure Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels Taking Down the Splenic Flexure rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.
laparoscopic intersphincteric resection laparoscopic low anterior resection combined with peranal intersphincteric resection
laparoscopic approach group: instruments used: laparoscopic instruments mentioned at the arm description instruments: laparoscopic instruments mentioned in the laparoscopic rectal resection arm intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach

Primary Outcomes

Measure
Hospital stay.
time frame: 2 months

Secondary Outcomes

Measure
Duration of the intervention
time frame: 1 day
Amount of blood loss and rate of blood transfusion
time frame: 1 Day
The onset of intestinal motility.
time frame: 2 weeks
Pain score
time frame: the first two weeks in the postoperative period
Postoperative complications
time frame: 30 Days
30 days follow up for readmission in the postoperative period
time frame: 1 month
Clinical functional outcome of intersphincteric resection
time frame: 1 year
Local recurrence within 2 years
time frame: 2 years
Distant metastasis within 2 years
time frame: 2 years
conversion rate for laparoscopic ISR
time frame: 1 day

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients with low rectal carcinoma(The lowest margin of tumor located 3 cm from anal verge ; ≤ 2 cm from dentate lines; 1 cm from anorectal rings. - Local spread restricted to the rectal wall or the internal anal sphincter. - Adequate preoperative sphincter function and continence. - Absence of distant metastasis. Exclusion Criteria: - Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4. - Metastatic rectal cancer. - Those in Dukes stage D (T4 lesion). - Undifferentiated tumours. - Local infiltration of external anal sphincter or levator ani muscles. - Tumor located more than 2 cm above the dentate line. - Presence of fecal incontinence. - Patients unwilling to take part in the study.

Additional Information

Official title Short Term Outcomes of Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
Description The management of rectal cancer has changed substantially during the recent decades. The introduction of total mesorectal excision, improved accuracy of preoperative staging with magnetic resonance imaging, and more precise indications for neoadjuvant radiotherapy or chemoradiotherapy represent significant progress. Ideal surgery for rectal cancer should not only obtain adequate radial and circumferential margins, but also preserve normal sphincter function. Successful excision of a low rectal tumour while preserving the anal sphincter requires knowledge of the pattern of tumour spread and an understanding of the physiology of the sphincter mechanism. The move towards sphincter preserving surgery began with early anorectal physiology work that showed the distal 1-2 cm of the rectum and internal anal sphincter not to be absolutely necessary for continence. Sphincter preservation presents several advantages; The first is the threefold lower risk of intraoperative rectal perforation and positive circumferential margin than APR. This is because TME with sphincter preservation is a more anatomical and standardized surgical procedure than APR. The second advantage is the better genital function observed after low anterior resection than after APR: 72-90% vs. 63-75%. This is due to the lower risk of damaging the pelvic branches of the pelvic autonomic nerve, which are exposed during the perineal phase of an APR. The third advantage of conservative surgery is preservation of the body image that may increase quality of life. The goal of intersphincteric resection is to divide the rectum transanally and to remove part or the whole of the internal anal sphincter, in order to obtain adequate distal margin and preserve the natural function of defecation. ISR is used mainly in Europe and more recently in Asia. This technique modified the concept of sphincter preservation, because it permits theoretically to avoid APR in all rectal cancers due to possibility to obtain safe distal margin in all cases. Series of intersphincteric resection confirm the safety of the procedure with 1.6% mortality, 10% of anastomotic leak, 9% of local recurrence and 81% of 5-year survival in a pooled analysis of 612 patients treated in 13 units by ISR for T2 T3 low rectal cancer. Preoperative chemoradiation therapy is widely used to treat locally advanced rectal cancer to increase resectability, and to enhance sphincter preservation, local control and possibly, survival rates. Surgery is performed six to eight weeks after radiotherapy. The exact level of transection of the internal sphincter is decided before radiation and according to the distance from the anal verge, in order to avoid underestimation of the irradiated tumors and potential risk of tumour transection. The advent of minimally invasive surgical techniques has given surgeons the option of a laparoscopic approach. Recently, the clinical outcome of intersphincteric resection (ISR) as a laparoscopic approach (laparoscopic ISR) has been reported, but laparoscopic ISR for patients with bulky low rectal cancer remains challenging particularly for T3 tumors in patients with a narrow pelvis, because of the difficulty in understanding the accurate anatomy of the small pelvic cavity, in dissecting the TME or the tumour specific mesorectal excision (TSME) plane, and in transecting the lower rectum safely. Total mesorectal excision (TME), negative circumferential margin (CFM), and tumor free surgical margin are prerequisites regardless of approach of ISR. Current evidence suggests that local recurrence, lymph node harvest and oncological clearance laparoscopic rectal resection are not compromised and may be equivalent to those of open surgery. Moreover, Numerous studies have demonstrated that laparoscopic techniques have many advantages in colorectal surgery compared with open surgery.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Mansoura University.