Rectum Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREpreserving 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 .
PROCEDUREnot 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.
Sponsors
Jian Suo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology. * The rectum cancer is the first malignant neoplasm the patient has got. * The cancer is solitary, and is 3cm to 20cm to the anus. * The surgical method is limited to Dixon.
Exclusion criteria
* Being in the acute phase of inflammation before operation and emergency surgery. * Patients receiving steroid medication or preoperative radiotherapy。 * Discovering macrometastasis before or in the operation. * The rectum cancer that can't be radical resected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Blood Pressure of the Arterial Arcade | after ligating the inferior mesentric artery or superior rectal artery |
Secondary
| Measure | Time frame |
|---|---|
| Distal Colon Length | after digestive tract reconstruction |
Other
| Measure | Time frame |
|---|---|
| Systemic Blood Pressure | after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon |
Countries
China
Participant flow
Recruitment details
69 Chinese patients from the First Hospital of Jilin University were recruited for the study between February 2013 and December 2013 .
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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 . | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Left Colic Artery Preserved | High Ligation of IMA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 22 Participants | 39 Participants |
| Age, Continuous | 62.1 years | 59.3 years | 60.7 years |
| Region of Enrollment China | 28 participants | 29 participants | 57 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 3 / 29 | 1 / 28 |
Outcome results
Primary
The Blood Pressure of the Arterial Arcade
Time frame: after ligating the inferior mesentric artery or superior rectal artery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Ligation of IMA | The Blood Pressure of the Arterial Arcade | 42.31 mmHg | Standard Deviation 1.85 |
| Left Colic Artery Preserved | The Blood Pressure of the Arterial Arcade | 48.50 mmHg | Standard Deviation 2.48 |
Secondary
Distal Colon Length
Time frame: after digestive tract reconstruction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Ligation of IMA | Distal Colon Length | 20.03 cm | Standard Deviation 3.27 |
| Left Colic Artery Preserved | Distal Colon Length | 21.29 cm | Standard Deviation 4.91 |
Other Pre-specified
Systemic Blood Pressure
Time frame: after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Ligation of IMA | Systemic Blood Pressure | 82.86 mmHg | Standard Deviation 10.17 |
| Left Colic Artery Preserved | Systemic Blood Pressure | 81.21 mmHg | Standard Deviation 11.58 |