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There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.
Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.
However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.
This study is planned as a phase II study.
There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-port laparoscopic distal gastrectomy | Active Comparator | Laparoscopic distal gastrectomy using the conventional 5-port access |
|
| Single incision distal gastrectomy | Active Comparator | Pure single incision distal gastrectomy using one transumbilical incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approach Method | Procedure | SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain score using VAS at postoperative day#1 | Maximum postoperative pain using the visual analogue scale | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Time spent during operation | Time during operation |
| Estimated blood loss | Amount of blood loss during operation | During operation |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hoon Ahn, M.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Early postoperative complication | Postoperative complications within 30 days from the operation | within 30 days from the operation |
| Hospital stay | Days until discharge | Days until discharge |
| Time to first flatus | Days until first flatus | Days until first flatus |
| Time to first soft fluid diet | Days until first soft fluid diet | Days until first soft fluid diet |
| Maximum pain scores using VAS | Maximum pain scores using the visual analogue scale | From postoperative day 0 to 5 |
| EORTC-C30 and STO22 | Quality of life questionnaires | Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |