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Genito Urinary Function With High or Low Inferior Mesenteric Artery Ligation in Laparoscopic Anterior Rectal Resection

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ClinicalTrials.gov Identifier: NCT02153801
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Brief Summary:
The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.

Condition or disease Intervention/treatment Phase
Genito Urinary Function Evaluation Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . Not Applicable

Detailed Description:

The level of arterial ligation can affect genito-urinary function (injury to the superior hypogastric plexus), extent (and yield) of lymphadenectomy, distal colonic arterial perfusion (distal colonic arterial perfusion could be deficient due to degenerative disease), sympathic nerve injures. Moreover, colonic stump blood supply together with anastomosis tension are the main factors in developing leaks in rectal surgery and is dependent of the level of ligation. The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.

Genito-urinary function will be evaluated with IIEF-5, Internation Consultation Incontinence Modular Questionnarie (ICIQ), Female Sexual Function Index (FSFI), International Index of erectile Function (IIEF) questionnaries and uroflowmetric test pre operatively.

Surgery will be as follow:

The following steps are required in all cases, independently of randomization. The first step consist in the opening of the left part of the gastrocolic ligament and the division of the left part of transverse mesocolon. The splenocolic and phrenocolic attachments are then divided, achieving complete dissection of the left colonic angle. The pelvic peritoneum is opened below the sacral promontory and the hypogastric nerves are identified and preserved. The common iliac veins, the genitofemoral nerve, the gonadic vessels, and the left ureter are successively identified and preserved.

For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.

For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.

For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.

Once the descending colonic tract is completely detached from the left parietocolic gutter, dissection of the rectum starts by incision of the peritoneal fold in the pelvis. Total Mesorectal Excision (TME) is then performed according to the principles of Heald.

Colonoscopy will be performed 30 days after surgery to evaluate the anastomosis (leakage, signs of ischemia. Accurate description and pictures of the anastomosis will be produced. IIEF-5, ICIQ, FSFI, International Index of erectile Function (IIEF) and uroflowmetric test will be performed 1 and 9 months post-operatively


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low Inferior Mesenterci Artery Ligation
The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .

For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.

For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.

For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.


High Inferior Mesenterci Artery Ligation

For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.

For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.

Procedure: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .

For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.

For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.

For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.





Primary Outcome Measures :
  1. Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires [ Time Frame: 9 months from laparoscopic RAR + TME ]

Secondary Outcome Measures :
  1. Incidence of anastomotic leak [ Time Frame: 1 month from laparoscopic RAR + TME ]
  2. Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires [ Time Frame: 1 month from laparoscopic RAR + TME ]
  3. Urinary Function assessed with Uroflowmetric examination [ Time Frame: 1 months from laparoscopic RAR + TME ]
  4. Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires [ Time Frame: 9 month from laparoscopic RAR + TME ]
  5. Urinary Function assessed with Uroflowmetric examination [ Time Frame: 9 months from laparoscopic RAR + TME ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • middle or low rectal cancer (from 0 to 12 cm from the anal verge), American Society Anesthesiologist (ASA) I II III, Body Mass index (BMI) lower than 30.

Exclusion Criteria:

  • prior surgery on the abdominal aorta,
  • conversion to laparotomy,
  • intraoperative decision for colostomy.

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): NCT02153801


Locations
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Italy
Raffaele Pugliese
Milano, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Investigators
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Study Director: Giulio Mari, MD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT02153801     History of Changes
Other Study ID Numbers: EudraCT Number 986
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Niguarda Hospital:
High Ligation, Low ligation, Genito-urinary function, laparoscopy, rectal cancer, aterior resection, Total mesorectal Excision, anastomotic leak.