An interventional study of preserving the left colic artery and not preserving the left colic artery in Rectum Cancer, sponsored by Jian Suo. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-06-06.
Sponsored by Jian Suo · Not applicable, Interventional, and Treatment
To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.
Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 57 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Jian Suo is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.
Procedure: preserving the left colic artery
We preserve the high ligation of the inferior mesenteric artery during the rectal surgery.
Procedure: not 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 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.
The Blood Pressure of the Arterial Arcade
Time frame: after ligating the inferior mesentric artery or superior rectal artery
Distal Colon Length
Time frame: after digestive tract reconstruction
Systemic Blood Pressure
Time frame: after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon
69 Chinese patients from the First Hospital of Jilin University were recruited for the study between February 2013 and December 2013 .
| Milestone | High Ligation of IMA | Left Colic Artery Preserved |
|---|---|---|
| Started | 29 | 28 |
| Completed | 29 | 28 |
| Not completed | 0 | 0 |
| mmHg | High Ligation of IMA | Left Colic Artery Preserved |
|---|---|---|
| The Blood Pressure of the Arterial Arcade | 42.31 ± 1.85 | 48.50 ± 2.48 |
| cm | High Ligation of IMA | Left Colic Artery Preserved |
|---|---|---|
| Distal Colon Length | 20.03 ± 3.27 | 21.29 ± 4.91 |
| mmHg | High Ligation of IMA | Left Colic Artery Preserved |
|---|---|---|
| Systemic Blood Pressure | 82.86 ± 10.17 | 81.21 ± 11.58 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Ligation of IMA | — | 3/29 (10.3%) | 0/29 (0%) |
| Left Colic Artery Preserved | — | 1/28 (3.6%) | 0/28 (0%) |
| Event | High Ligation of IMA | Left Colic Artery Preserved |
|---|---|---|
| anastomotic leakageSurgical and medical procedures | 3/29 | 1/28 |
| Age, Categorical(Participants) | High Ligation of IMA | Left Colic Artery Preserved | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 17 | 39 |
| >=65 years | 7 | 11 | 18 |
| Age, Continuous(years) | High Ligation of IMA | Left Colic Artery Preserved | Total |
|---|---|---|---|
| Mean | 59.3 (34 to 71) | 62.1 (45 to 81) | 60.7 (34 to 81) |
| Sex: Female, Male(Participants) | High Ligation of IMA | Left Colic Artery Preserved | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 16 | 17 | 33 |
| Region of Enrollment(participants) | High Ligation of IMA | Left Colic Artery Preserved | Total |
|---|---|---|---|
| China | 29 | 28 | 57 |
Plan to share: No
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