TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

NCT01836926 | Completed DMC

• 1 other identifier: Mansoura oncology centre
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rectal Cancer

Keywords

sphincter sparing procedures; intersphincteric resection; rectal cancer; ultralow rectal cancer; sphincter preserving procedures; Abdominoperineal resection; Trans-anal minimally invasive surgery; TAMIS versus open colorectal resection; neoadjuvant chemo-radiotherapy for rectal cancer

Outcome Measures

Primary Outcomes (1)

• Early Complications number

  2 years

Secondary Outcomes (11)

• Duration of the intervention

  1 day

• Amount of blood loss and rate of blood transfusion

  1 Day

• conversion rate for open ISR

  1 day

• The onset of intestinal motility.

  2 weeks

• Pain score

  the first two weeks in the postoperative period

Study Arms (2)

Open intersphincteric resection

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.

Procedure: Open intersphincteric resection

laparoscopic intersphincteric resection .

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: 1. Trocar Placement and Exposure 2. Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels 3. Taking Down the Splenic Flexure 4. rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.

Device: transanal minimally invasive intersphincteric resection

Interventions

Open intersphincteric resection PROCEDURE

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

Also known as: sphincter preserving procedures in low rectal cancer, very low rectal cancer resection, interspincteric resection

Open intersphincteric resection

transanal minimally invasive intersphincteric resection DEVICE

minimally invasive 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

Also known as: laparoscopic low anterior resection combined with trans-anal endoscopic intersphincteric resection, lTAMIS

laparoscopic intersphincteric resection .

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osama Mohammad Ali ElDamshety: lead
• Mansoura University: collaborator
• Marche Polytechnic university, Ancona, Italy: collaborator

Study Sites (2)

Mansoura oncology centre

Al Mansurah, Dakahlia Governorate, Egypt

Location

Mansoura university oncology centre

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (1)

• [1] Zeeneldin A, Saber M, Seif El-din I, Frag S. Colorectal carcinoma in Gharbiah district, Egypt: Comparison between the elderly and non-elderly. Journal of Solid Tumors 2012; Vol. 2, No. 3. [2] Heald RJ, Husband EM, Ryall RD The mesorectum in rectal cancer surgery-the clue to pelvic recurrence? Br J Surg 1982; 69:613-616 [3] Daniels IR, Fisher SE, Heald RJ, Moran BJ. Accurate staging, selective preoperative therapy and optimal surgery improves outcome in rectal cancer: a review of the recent evidence. Colorectal Dis 2007; 9: 290-301. [4] Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S et al. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet 2009; 373: 811-820. [5] Bai X., Li S., Yu B., Su H., Jin W., Chen G., Du J. And Zuo F. Sphincter-preserving surgery after preoperative radiochemotherapy for T3 low rectal cancers. Oncology Letters 2012; 3: 1336-1340 [6] Tytherleigh MG and Mortensen MN. Options for sphincter preservation in surgery for low rectal cancer , British Journal of Surgery 2003; 90: 922-933 DOI: 10.1002/bjs.4296 [7] Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg 1994; 81: 1376-1378. [8] Kapiteijn E, Marijnen CA, Nagtegaal ID et al Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 2001; 345:638-646

  RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: oncology surgeon--Oncology Centre of Mansoura University (OCMU)

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 22, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

EG (2)