Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708678
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2021-01-12
Brief Title:
Long-term Efficacy of Doppler Ligation With Mucopexy in the Treatment of Internal Hemorrhoidal Disease
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Long-term Efficacy of Doppler Ligation With Mucopexy in the Treatment of Internal Hemorrhoidal Disease
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEM_THD
Brief Summary:
A classic distinction is made between internal and external hemorrhoidal pathology External hemorrhoids can present with thrombosis which causes painful swelling internal hemorrhoids by rectal bleeding prolapse and more rarely thrombosis Hemorrhoidal pathology is one of the most frequent reasons for consultation in proctology Its prevalence is probably underestimated due to taboos and the frequent self-medication of patients but it is considered high in the general population
The therapeutic management of internal or external hemorrhoidal pathology is primarily based on hygiene and dietetic measures and regularization of transit In the case of external hemorrhoidal pathology treatment may also include Non-Steroidal Anti-Inflammatory Drugs NSAIDs and topical treatment anesthetic or topical corticosteroid For internal hemorrhoidal pathology when these measures are insufficient or when prolapse is present from the outset instrumental treatment can be offered allowing the bleeding and or prolapse to be treated up to grade 3 maximum This treatment includes sclerosis less and less practiced infrared photocoagulation and rubber band ligation In 10 to 20 of cases when the prolapse is irreducible there is anemia of hemorrhoidal origin or the symptoms persist despite well-conducted treatment surgical treatment may be offered
The reference surgical technique in France and in Europe is tripedicular hemorrhoidectomy according to the Milligan and Morgan technique developed at Saint Marks Hospital in London first published in 1937 It has the advantage of to be the most effective technique with a low rate of postoperative recurrence and treats both internal and external hemorrhoidal pathology However the postoperative period is painful requires local care and requires cessation of activity for several weeks On the other hand there is a risk of potentially serious complications and permanent sequelae acute retention of urine 21-15 hemorrhage 06-54 anal stenosis 6 infection 05-5 and anal incontinence 0-6 Patient selection is essential and contraindicates hemorrhoidectomy in cases of anal incontinence active suppuration chronic inflammatory bowel disease anal intercourse or a history of pelvic radiotherapy
As an alternative to hemorrhoidectomy and its painful and restrictive consequences new minimally invasive surgical techniques that have proven their effectiveness in the treatment of internal hemorrhoidal pathology have emerged over the past twenty years The two main ones are Longo circular stapling hemorrhoidopexy and Doppler-controlled arterial ligations with mucopexy Several studies have shown that Longos hemorrhoidopexy causes less postoperative pain and allows a faster return to activity than after a tripedicular hemorrhoidectomy On the other hand the rate of recurrence of hemorrhoidal pathology was higher This rate was 41 at 12 years and 475 at 15 years In addition specific and severe complications have been described as rectal perforations rectovaginal fistulas perirectal hematomas pelvic cellulitis peritonitis and death
Several comparative studies have shown that arterial ligation under Doppler control with mucopexy was less painful postoperatively than hemorrhoidopexy by circular stapling and that the short- and medium-term efficacy was generally similar In addition the postoperative consequences of arterial ligatures under Doppler control with mucopexy seem harmless with none of the major complications described after stapled hemorrhoidopexy For these reasons arterial ligation is now tending to replace hemorrhoidopexy with circular stapling
The objective of our study is to assess the rate of recurrence of long-term hemorrhoidal pathology in patients who have had arterial ligatures under Doppler control with mucopexy at our center The results will help guide the practitioner and the patient in the choice of surgical treatment
The therapeutic management of internal or external hemorrhoidal pathology is primarily based on hygiene and dietetic measures and regularization of transit In the case of external hemorrhoidal pathology treatment may also include Non-Steroidal Anti-Inflammatory Drugs NSAIDs and topical treatment anesthetic or topical corticosteroid For internal hemorrhoidal pathology when these measures are insufficient or when prolapse is present from the outset instrumental treatment can be offered allowing the bleeding and or prolapse to be treated up to grade 3 maximum This treatment includes sclerosis less and less practiced infrared photocoagulation and rubber band ligation In 10 to 20 of cases when the prolapse is irreducible there is anemia of hemorrhoidal origin or the symptoms persist despite well-conducted treatment surgical treatment may be offered
The reference surgical technique in France and in Europe is tripedicular hemorrhoidectomy according to the Milligan and Morgan technique developed at Saint Marks Hospital in London first published in 1937 It has the advantage of to be the most effective technique with a low rate of postoperative recurrence and treats both internal and external hemorrhoidal pathology However the postoperative period is painful requires local care and requires cessation of activity for several weeks On the other hand there is a risk of potentially serious complications and permanent sequelae acute retention of urine 21-15 hemorrhage 06-54 anal stenosis 6 infection 05-5 and anal incontinence 0-6 Patient selection is essential and contraindicates hemorrhoidectomy in cases of anal incontinence active suppuration chronic inflammatory bowel disease anal intercourse or a history of pelvic radiotherapy
As an alternative to hemorrhoidectomy and its painful and restrictive consequences new minimally invasive surgical techniques that have proven their effectiveness in the treatment of internal hemorrhoidal pathology have emerged over the past twenty years The two main ones are Longo circular stapling hemorrhoidopexy and Doppler-controlled arterial ligations with mucopexy Several studies have shown that Longos hemorrhoidopexy causes less postoperative pain and allows a faster return to activity than after a tripedicular hemorrhoidectomy On the other hand the rate of recurrence of hemorrhoidal pathology was higher This rate was 41 at 12 years and 475 at 15 years In addition specific and severe complications have been described as rectal perforations rectovaginal fistulas perirectal hematomas pelvic cellulitis peritonitis and death
Several comparative studies have shown that arterial ligation under Doppler control with mucopexy was less painful postoperatively than hemorrhoidopexy by circular stapling and that the short- and medium-term efficacy was generally similar In addition the postoperative consequences of arterial ligatures under Doppler control with mucopexy seem harmless with none of the major complications described after stapled hemorrhoidopexy For these reasons arterial ligation is now tending to replace hemorrhoidopexy with circular stapling
The objective of our study is to assess the rate of recurrence of long-term hemorrhoidal pathology in patients who have had arterial ligatures under Doppler control with mucopexy at our center The results will help guide the practitioner and the patient in the choice of surgical treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None