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Laparoscopic Versus Open Intersphincteric Resection and Total Mesorectal Excision of Stage II/III Ultralow Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy. (ISR)

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ClinicalTrials.gov Identifier: NCT01836926
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Mansoura University
University of Roma La Sapienza
Information provided by (Responsible Party):
Osama Mohammad Ali ElDamshety, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Open intersphincteric resection Device: laparoscopic intersphincteric resection Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Intersphincteric Resection and Total Mesorectal Excision of Stage II/III Ultralow Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy.
Study Start Date : April 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Active Comparator: Open intersphincteric resection
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

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

Other Names:
  • sphincter preserving procedures in low rectal cancer
  • very low rectal cancer resection
  • interspincteric resection

Active Comparator: laparoscopic intersphincteric resection .

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: laparoscopic 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
Other Name: laparoscopic low anterior resection combined with peranal intersphincteric resection




Primary Outcome Measures :
  1. Hospital stay. [ Time Frame: 2 months ]
    Outcome observers will assess the hospital stay days after both procedures


Secondary Outcome Measures :
  1. Duration of the intervention [ Time Frame: 1 day ]
    Duration of surgery

  2. Amount of blood loss and rate of blood transfusion [ Time Frame: 1 Day ]
    Amount of blood loss and blood transfusion through the operation

  3. The onset of intestinal motility. [ Time Frame: 2 weeks ]
    the onset of the intestinal motility guided by (the onset of borborygmus and its sequence, time to give off flatus, time to intake liquid and solid food)

  4. Pain score [ Time Frame: the first two weeks in the postoperative period ]
    Recording of the needed analgesia guided by pain score

  5. Postoperative complications [ Time Frame: 30 Days ]
    complications will be reported through the first 30 days postoperative

  6. 30 days follow up for readmission in the postoperative period [ Time Frame: 1 month ]
    readmission within 30 days after patient discharge

  7. Clinical functional outcome of intersphincteric resection [ Time Frame: 1 year ]
    Investigators will assess the functional outcome (through kirwan score for assessment of the continence) of intersphincteric resection combined with Total mesorectal excision for low rectal cancer 3 months postoperative and after closure of ileostomy and permnant diversion due to incontinence

  8. Local recurrence within 2 years [ Time Frame: 2 years ]
    The patients will be observed after the operation for 2 years for local pelvic recurrence

  9. Distant metastasis within 2 years [ Time Frame: 2 years ]
    Distant metastasis after the opertaion for 2 years

  10. conversion rate for laparoscopic ISR [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836926


Locations
Egypt
Mansoura oncology centre
Mansoura, El Dakahlia, Egypt
Mansoura university oncology centre
Mansoura, El-dakahlia, Egypt
Sponsors and Collaborators
Osama Mohammad Ali ElDamshety
Mansoura University
University of Roma La Sapienza

Publications of Results:
[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

Responsible Party: Osama Mohammad Ali ElDamshety, oncology surgeon--Oncology Centre of Mansoura University (OCMU), Mansoura University
ClinicalTrials.gov Identifier: NCT01836926     History of Changes
Other Study ID Numbers: Mansoura oncology centre
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Keywords provided by Osama Mohammad Ali ElDamshety, Mansoura University:
sphincter sparing procedures
intersphincteric resection
rectal cancer
low rectal cancer
sphincter preserving procedures
Abdominoperineal resection
laparoscopic resection of rectal cancer
laparoscopic versus open colorectal resection
laparoscopic versus open rectal surgery
neoadjuvant chemo-radiotherapy for rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases