Trial Outcomes & Findings for Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery (NCT NCT01979029)

NCT ID: NCT01979029

Last Updated: 2016-06-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: after ligating the inferior mesentric artery or superior rectal artery
• Results posted on: 2016-06-06

Participant Flow

69 Chinese patients from the First Hospital of Jilin University were recruited for the study between February 2013 and December 2013 .

69 patients initially considered for the study, 11 were excluded because they didn't meet the including criteria. The remaining 58 patients were informed with regard to the study, but they remained blinded to the type of operative technique they would receive. Ultimately, one patient declined to participate in the study.

Participant milestones

Measure	High Ligation of IMA We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
Overall Study STARTED	29	28
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery

Baseline characteristics by cohort

Measure	High Ligation of IMA n=29 Participants We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved n=28 Participants We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	59.3 years n=5 Participants	62.1 years n=7 Participants	60.7 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment China	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: after ligating the inferior mesentric artery or superior rectal artery

Outcome measures

Measure	High Ligation of IMA n=29 Participants We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved n=28 Participants We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
The Blood Pressure of the Arterial Arcade	42.31 mmHg Standard Deviation 1.85	48.50 mmHg Standard Deviation 2.48

SECONDARY outcome

Timeframe: after digestive tract reconstruction

Outcome measures

Measure	High Ligation of IMA n=29 Participants We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved n=28 Participants We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
Distal Colon Length	20.03 cm Standard Deviation 3.27	21.29 cm Standard Deviation 4.91

OTHER_PRE_SPECIFIED outcome

Timeframe: after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon

Outcome measures

Measure	High Ligation of IMA n=29 Participants We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved n=28 Participants We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
Systemic Blood Pressure	82.86 mmHg Standard Deviation 10.17	81.21 mmHg Standard Deviation 11.58

Adverse Events

High Ligation of IMA

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Left Colic Artery Preserved

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	High Ligation of IMA n=29 participants at risk We performed the high ligation of the inferior mesenteric artery during the rectal surgery. not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.	Left Colic Artery Preserved n=28 participants at risk We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
Surgical and medical procedures anastomotic leakage	10.3% 3/29 • Number of events 3	3.6% 1/28 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jian Suo

First Hospital of Jilin University

Phone: 0431-88785605

Email: suojian42@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place